Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005111102

FEI Number

3005111102

Entity Name

CONTURA INTERNATIONAL A/S

City/State/Country

Soeborg Hovedstaden, DK

Establishment Address

Sydmarken 23, Soeborg Hovedstaden 2860, DK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Contura International A/S (Owner Number: 10062518)

Owner / Operator Contact Address

Sydmarken 23, Soeborg, DK-84 2860, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bulkamid Urethral Bulking System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2020-02-07

Official Correspondent

Carina Moldow

US Agent Details

Aaron Dunbar Business: BOSTON SCIENTIFIC CORPORATION Email: aaron.dunbar@bsci.com Phone: (651) 3961414

Related Public Records

Same Entity

Contura International A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005111102. Last updated year: 2026. Please use registration number 3005111102 when referencing this establishment in official correspondence.